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METformin and FINGER Intervention to Prevent Cognitive Impairment and Disability in Older Adults at Risk for Dementia

Study acronym: MET-FINGER
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Feb 28, 2027 to Jun 30, 2028 Trial status: Recruiting to Active, Not Recruiting · Completion date: Jun 28, 2027 to Jun 30, 2028 · Site details revised at 3 of 3 sites · 1 morev7 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jun 28, 2027 to Jun 30, 2028
    • Site details revised at 3 of 3 sites
    • Collaborators reordered
  2. Primary completion date: Aug 31, 2026 to Feb 28, 2027 Completion date: Dec 15, 2026 to Jun 28, 2027 · Site details revised at 2 of 3 sitesv6 Show 2 more changesShow less
    • Completion date: Dec 15, 2026 to Jun 28, 2027
    • Site details revised at 2 of 3 sites
  3. Trial status: Not Yet Recruiting to Recruiting Site details revised at 3 of 3 sitesv5 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  4. Start date: Nov 30, 2022 to Jan 25, 2023 Primary completion date: Jun 30, 2026 to Aug 31, 2026 · Completion date: Oct 15, 2026 to Dec 15, 2026 · Collaborators revised (9)v4 Show 3 more changesShow less
    • Primary completion date: Jun 30, 2026 to Aug 31, 2026
    • Completion date: Oct 15, 2026 to Dec 15, 2026
    • Collaborators revised (9)

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Oct 2025 to Jun 30, 2026 Start date: May 2022 to Nov 30, 2022 · Completion date: Dec 2025 to Oct 15, 2026v3 Show 2 more changesShow less
    • Start date: May 2022 to Nov 30, 2022
    • Completion date: Dec 2025 to Oct 15, 2026
  6. Eligibility criteria expanded, about 19 words Secondary endpoints revised (31)v2 Show 1 more changeShow less
    • Secondary endpoints revised (31)

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Dementia is the main cause of disability in older adults, currently affecting about 50 million people world-wide with this number estimated to triple in the next 30 years. In MET-FINGER, we aim to understand whether the FINGER 2.0 multidomain intervention, combining healthy lifestyle changes and a drug for diabetes (metformin), may help reduce the risk of dementia and improve health and independence among older adults. The study primary objective is to test the effect of the intervention, compared to healthy lifestyle advice, on the change in cognition, measured as a composite score including 14 of neuropsychological/cognitive tests. The secondary objective is to test the intervention effect on change in individual cognitive domains, functioning level, and risk factors for dementia (e.g., lifestyle, medical, and psychosocial). To this aim, a range of personal/health-related data and blood samples, will be collected. Potential interactions between metformin and lifestyle changes; potential disease-modifying effects; and feasibility of the metformin + lifestyle combination will be explored. 600 older people with risk factors for dementia, but without dementia/substantial cognitive impairment, will be recruited in the United Kingdom, Finland, and Sweden (at least 50% with higher genetic risk of Alzheimer's Disease/dementia based on the Apolipoprotein E (APOE) gene). Participants will be randomly assigned 1:1 to either a self-guided multidomain lifestyle intervention or to the FINGER 2.0 multidomain lifestyle-based intervention. Outcome assessors will be blinded to group allocation. Within the FINGER 2.0 intervention group, participants at increased risk of diabetes, will be randomly assigned 1:1:1 to either the metformin 2000mg/day, metformin 1000mg/day, or placebo group (double blinded). The intervention duration is 24 months. The lifestyle intervention includes four main components: physical exercise, diet, brain training and health checks. In the self-guided group, participants will create their own program, based on health advice and recommendations which will be provided during the study. In the FINGER 2.0 intervention group, participants will receive intensive lifestyle guidance, and participate in structured activities, which will be as tailored as possible on each person's daily habits and needs. Over the 2-year study period, all participants will attend four assessment visits: baseline, 6-, 12-, and 24-months.
Trial Details
NCT Number NCT05109169
Lead Sponsor Imperial College London
Collaborators: Alzheimer's Drug Discovery Foundation, Alzheimerfonden, Region Stockholm, Merck KGaA, Darmstadt, Germany, Finnish Institute for Health and Welfare, Fingers Brain Health Institute, Karolinska University Hospital, Karolinska Institutet, Alzheimer's Association
Conditions Cognitive Decline, Cognitive Impairment, Dementia
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov